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Table 3 Experimental results for the compound C25H25N8O4Cl, HCl

From: Mat-CHN software for drug substance titrations in discovery and development

Analytical determination

Method

Experimental results (%w/w)

Water content

Karl Fischer

0.80

Water content

Karl Fischer

0.85

Butanol-1

CPG-head space

0.35 (3500 ppm)

Chloride ion content

Ionic chromatography

6.21(1)

Chloride ion content

Ionic chromatography

5.82(1)

Chloride ion content

Ionic chromatography

6.03(1)

Des-chlorinated Impurity

HPLC

0.3

Di-chlorinated Impurity

HPLC

0.6

%C

Elemental analysis

51.720

%H

Elemental analysis

4.708

%N

Elemental analysis

19.054

  1. 1As a remainder, each of these individual results will be divided by 3 (three values for the same series of results) for Mat-CHN exploitation